In its Final Written Decision, the Board found that Petitioner showed by a preponderance of the evidence that claims 17-23 of the ‘997 patent are unpatentable, but that Petitioner had not shown that claims 9-16 and 24-30 are unpatentable.
The ‘997 patent is related to “methods and instrumentation for performing surgery on the spine along its lateral aspect.” With respect to claim construction, the Board set forth an explicit construction for two claim terms. First, the Board adopted the parties’ agreed-upon construction of “axis lying in a coronal plane” as an axis lying in “a plane at right angles to a sagittal plane.” Second, the Board addressed the construction of the term “elongated portion.” Patent Owner argued that the term should require that the portion have a length “substantially greater than its width.” However, the Board found the “substantially” limitation unsupported by the specification, and thus, construed the term as a portion “having a length that is greater than the width of the elongated portion.”
The Board then addressed the instituted grounds of unpatentability, discussing the six instituted grounds in two groups: grounds based on the references Jacobson, Leu, and Brantigan (claims 17-23) and grounds based on Jacobson, Leu, and Michelsen (claims 9-16 and 24-30).
Claims 17-23
The Board first addressed Patent Owner’s arguments regarding claims 17-23, finding each unpersuasive. First, Patent Owner argued that Jacobson does not disclose what it described as a “direct lateral” approach to the spine in performing surgery. Patent Owner attempted to distinguish the claims, arguing that while Jacobson discloses one type of lateral approach, the claims are limited to a “direct lateral” approach. The Board found this argument unpersuasive based upon the construction of the term lateral. Nevertheless, the Board was persuaded that Jacobson discloses the so-called “direct lateral” approach anyway.
Patent Owner also attacked the Jacobson reference for allegedly failing to disclose the insertion of an implant because the procedure disclosed in Jacobson (a fusion surgical procedure) does not necessarily require an implant. The Board agreed with Patent Owner that an implant is not inherently disclosed by the procedure in Jacobson. However, the Board found the argument irrelevant, because the instituted grounds of unpatentability are based on obviousness and not anticipation, to which inherency would be relevant.
The Board then turned to Patent Owner’s arguments with respect to distinguishing the reference Brantigan from claim 17. Patent Owner primarily argued that Brantigan does not disclose an implant shaped or sized “to extend onto the apophyseal ring of the vertebral body or an implant being sized to extend beyond a central region of a vertebral body.” First, the Board found the argument and accompanying expert testimony unpersuasive because Patent Owner failed to show that the claims recited such limitations. Also, the Board found, based upon its construction of “disc space” to “include a space between adjacent vertebral bodies,” that Brantigan discloses such an implant.
The Board next addressed Patent Owner’s argument that Leu does not disclose “a spinal fusion implant” but rather discloses a “graft conglomerate” containing impacted bone and soft cancellous bone that “is not a structural implant.” First, the Board was not persuaded because Patent Owner failed to demonstrate that claim 17 recites that the implant must not contain impacted bone or soft cancellous bone. The Board also credited Petitioner’s declarant’s testimony for showing that a person of ordinary skill in the art would understand that “non-bone elements” could be inserted in the disc space for interbody fusion. In addition, the Board held that even if Leu did not disclose an implant, the limitation was disclosed by Brantigan anyway.
The Board next disposed of Patent Owner’s argument related to the “elongated portion” term because it was based on the proposed claim construction that the Board had not adopted.
With respect to the combinability of the references, the Board first stated that it agreed with Petitioner’s argument that claim 17 was no more than a “combination of familiar elements according to known methods” that resulted in a predictable and expected result. The Board rejected Patent Owner’s arguments that the proposed combination would widen a needle puncture perforation without warning to the surgeon and that Brantigan taught away from the claims because the arguments were contrary to the disclosure of the references. The Board was also not persuaded by Patent Owner’s argument that the references are not physically combinable, stating that the test is “what the combined teachings of those references would have suggested.”
Next, the Board addressed evidence of secondary considerations. With respect to commercial success, Patent Owner argued that Petitioner’s allegedly successful products were touted for several features. However, the Board was not persuaded because Patent Owner failed to demonstrate a nexus between the merits of the claimed invention and the evidence offered. In particular, Patent Owner did not establish that many of the touted features in Petitioner’s products were recited in the claims. Further, even if recited in the claims, the Board held that Patent Owner did not demonstrate that the sales figures had a sufficient nexus to the touted product features cited by Patent Owner. The Board also highlighted the marketing materials for the allegedly successful products, noting that several features other than those cited by Patent Owner were advertised as providing benefits.
With respect to industry praise, the Board held that Patent Owner failed to demonstrate that the alleged praise had a sufficient nexus to features recited in the claims. In this regard, some of the praise was directed to features that were already known in the art such that there could be no nexus, and other praise concerned features that were not shown to be recited in the claims.
Turning to copying, the Board noted that evidence of copying would be given little weight where the copy is not identical to a product embodying the claimed invention. The Board then held that Patent Owner failed to demonstrate that the alleged copy was identical to a product embodying the claimed invention. Thus, little weight was given to the evidence. The Board went further and stated that even if the copy was an identical copy, Patent Owner had still not established that the product embodied the claims.
Claims 9-16 and 24-30
Petitioner’s arguments regarding claims 9-16 and 24-30 depended upon the disclosure of Michelson. After considering both parties’ arguments, the Board found that Petitioner had not established that Michelson disclosed the recited features. Thus, the Board was not persuaded that claims 9 and 24 and their dependent claims would have been obvious.
Motion to Exclude
The Board dismissed Patent Owner’s Motion to Exclude. Patent Owner argued that a second declaration of Dr. McAfee should be excluded for improperly relying upon Dr. Jacobson’s declaration regarding surgeries performed prior to 1995, which were allegedly irrelevant to patentability. The Board noted that the declaration was relied upon to support what a person of ordinary skill in the art would have understood and should not be excluded.
Patent Owner also moved to exclude a portion of the Jacobson Declaration. However, the Board stated that the declaration was relied upon for similar reasons as the McAfee Declaration and should not be excluded.
Other evidence Patent Owner sought to exclude was not relied upon by the Board, and the motion was therefore moot with respect to that other evidence.
Nuvasive, Inc. v. Warsaw Orthopedic, Inc., IPR2013-00206
Paper 65: Final Written Decision
Dated: July 10, 2014
Patent: 8,251,997 B2
Before: Sally C. Medley, Lora M. Green, and Stephen C. Siu
Written by: Siu